FDA Fast-Tracks Enobia’s Enzyme Replacement Therapy

20 May 2009 (Last Updated May 20th, 2009 18:30)

The US Food and Drug Administration (FDA) has granted fast-track status to Enobia Pharma's enzyme replacement therapy ENB-0040. The therapy is being developed for the treatment of hypophosphatasia (HPP), a rare and potentially genetic life-threatening bone disease. The FDA has gr

The US Food and Drug Administration (FDA) has granted fast-track status to Enobia Pharma's enzyme replacement therapy ENB-0040.

The therapy is being developed for the treatment of hypophosphatasia (HPP), a rare and potentially genetic life-threatening bone disease.

The FDA has granted fast-track designation in part because HPP is an untreated, serious and potentially life-threatening disorder.

Enobia chief medical officer and VP of medical affairs Hal Landy said the company was pleased that the FDA has recognised that ENB-0040 may provide a much-needed treatment for patients with this devastating inherited bone disease.

The company will now have access to discussions and communications with the regulator to facilitate the ENB-0040 development and review process.